PMCF Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms

C.O.C. Farmaceutici

Status

Completed

Conditions

Dry Eye

Dry Eye Disease

Kerato Conjunctivitis Sicca

Treatments

Device: Carmellose eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT05825352

COC-R4-CMC

Details and patient eligibility

About

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance.

Tear Film & Ocular Surface Society Dry Eye Workshop (TFOS DEWS) II recommends individualized management of DED based on the relative contribution of aqueous deficient and evaporative pathophysiology (to the extent that this can be determined), as well as disease severity.

First-line for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants.

Carboxymethyl cellulose (CMC) is one of the most common viscous polymers used in artificial tears to achieve prolonged residence time on the ocular surface.

For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Ocular drops based upon carmellose" used as intended to relieve dry eye symptoms.

The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Ocular drops based upon carmellose" according the Instructions for Use (IFU).

Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed.

At baseline visit (V0), one of the "Ocular drops based upon carmellose" products can be dispensed to the enrolled subject, depending on Investigator clinical evaluation and decision.

The patient will perform 2 on site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according the IFU, depend on various factors regarding the physiology of the patients (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses) and their eye-surgery history (if applicable).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient Informed consent form (ICF) signed;
Male and Female Aged ≥ 18 years at the time of the signature of the ICF;
Patients with ocular symptoms such as burning, itching, and foreign body sensation due to environmental factors, contact lenses wearing and/or mild-severe dry eye;
Willing not to use other eye drops during the entire treatment period.

Exclusion criteria

Other - different - eyes clinical conditions (e.g. glaucoma);
Known hypersensitivity or allergy to Investigational Product (IP) components;
Suspected alcohol or drug abuse;
Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases, diabetes);
Participation in another investigational study;
Inability to follow all study procedures, including attending all site visits, tests and examinations;
Mental incapacity that precludes adequate understanding or cooperation.